Former FDA Chairman, Pfizer CEO and MSNBC Paid Contributor Explains Trial Extension

The FDA, who asked Pfizer to submit an application for 6 mo. to 4 year old, has now asked for a delay.  Scott Gottlieb, a poster boy for the revolving door between government regulatory agencies, the industry they regulate and the media who should function as watch dogs for the public tries to explain why.

Because a clinical case of Covid19 is so rare in children in this age group Pfizer’s study is having trouble getting any workable results from the infant up to 4 year old trials.  Gottlieb stated that “most kids are not getting symptomatic Covid.  One case in one direction or an other can tip the perception of the vaccine’s overall effectiveness”.

This was also the case in the original adult trials for Pfizer.  Out of approximately 40,000 adult trial participants only 170 came down with Covid19 in a 6 month period.  Pfizer is now, with toddlers and infants, trying to make evaluations that are 100s if not 1000s of times smaller in terms of clinical evidence.  Compounding this problem is the use of a smaller cohort and, even with the trial extended, a shorter time frame of evaluation.